Instructions For Use (IFU)
1. Use Of Apparel
- Radiation Protection Apparel is used to protect the operators against secondary or scattered radiation during conventional and interventional radiology procedures.
- We comply with IEC 61331-1:2014 and IEC 61331-3:2014 standards.
Coat Apron, Surgical Apron and Dental Apron
To dress, wear it through the hands from the rear side and fasten the velcro. Ensure that the apron is tightened enough. To undress, pull out the waist velcro closures and remove through the hands.
Skirt and Vest
To dress, wear the vest through the shoulder, close the 2 sides on the front and fasten on the velcro. Tighten if needed with the stretch belt provided. To take it out pull out the velcro closures and remove through the shoulder. To wear the skirt, spread it across the waist and tighten by closing the velcro. If needed use the buckle to lock the skirt and to take it out pull out the velcro closures and remove through the waist.
Patient Apron
To dress, lock it with the help of the lock provided as an adjustable back strap for snug fit at the back so that it can be easily held over the patient waist. Ensure that the apron is tightened enough so that it does not come off easily. To undress, unlock the lock and remove the apron.
Double Sided Apron
To dress, wear it through the shoulder, close the 2 sides on the front and fasten on the velcro. Ensure that the apron is tightened enough. To undress, pull out the velcro closures and remove through the hands.
Thyroid Shield
Velcro or Magnetic closure provided for perfect fit
Head Shield
Adjustable velcro provided for good fit.
Gonad Shield
The shield is to be used by wearing it round the hips with the protection material covering the gonadal area. The adjustable back strap is to be tightened and locked using the buckle.
2. Care & Storage
- Don’t fold, crease, drape or sit down tightly on your apparel and accessories. Apparel need to be stored in apron racks.
- Keep your apparel clean by wiping away stains as soon as possible using cold water and mild detergent or a cleaning agent designed specifically for apron cleaning.
- Do not autoclave.
- Hook-and-loop closure must be secured properly to avoid snagging or tearing of fabric. Always store the apron with Hook-and-loop closure closed.
- Use an appropriate hanger system for storage of apparel.
- Never fold the apron or hang over edges.
- Maintain room temperature and humidity in accordance with the normal working conditions.
- Keep away from direct sunlight and heat.
- Apparel should first be cleaned with the manufacturer advised soap solution by gently rubbing on the fabric surface.
- Fresh stains or marks on the fabric surface can be removed using soap solution diluted to 1:10 by water. Apply soap solution on the stain, allow it to rest for a maximum of five minutes and then wipe it using wet cloth. We recommend soap solutions with no alcohol content. After wet cleaning, wipe the apparel with dry cloth and allow it to dry at room temperature.
- It is advisable to clean and maintain once in a month or as per usage.
3. Periodic Inspection
Since the aprons are used regularly and are a critical protective barrier from X-ray radiation they should be inspected and tested once in every 6 months.
- Lay the apron out on a clean, flat surface and visually inspect for any tears.
- Take note of the apron closures (velcro, buckles, etc.) to ensure that they are in proper working order.
- Closely inspect each item for kinks and irregularities.
- Take a radiograph of suspect areas if already marked during visual inspection.
- Process the image and look for breaks in the protective sheeting, typically appearing as dark or white spots based on image processing modalities.
- Run your hands over the entire surface of the apron to find any thinning of the lead or creases.
- Another method is to hand the apron on an apron rack and place one hand on the front and one hand directly on the back of the apron.
- Keeping your hands directly parallel to each other, slowly run both hands up and down the surface area of the apron, noting anywhere there is a thinning or creasing of the material.
- If any defect is observed such as cracks, thinning, lumps or accumulation etc then mark those areas such that the same area can be then checked with an X-ray scan.
4. Service Life & Disposal
The service life of apparel depends on use and care and varies enormously. If the apparel is
Damaged physically causing breakage or holes in protective material (which can be determined by physical observation)
OR
Protection material is hardened, due to migration of metal particles (which can be determined by physical observation or by noticing an uneven thickness in top portion and bottom portion of the apparel) then the apparel should not be used anymore.
Due to the high metallic content in the vinyl/rubber sheeting any waste material should be disposed of in registered landfill sites in accordance with the local authority regulations. The material should not be disposed of by incineration and use of self contained breathing apparatus is recommended if the sheeting is ignited by an internal fire.
If the protective apparel is not worn properly or not tightened enough there is a likelihood of it coming off, resulting in insufficient protection and injury. The user has to choose the correct size of Personal Protective Equipment.
5. Caution & Information
The function of the apparel is to provide protection from secondary radiation and not from the direct X-ray beam. Apparel should be worn only during the time of X-ray exposure. We have not come across allergies to users due to the apparel but the user may seek medical advice, if necessary.
If the apparel is worn for more than 2 hours continuously, it may cause tiredness and fatigue due to its weight. The time may vary from person to person. It is recommended that the apparel be removed for about 15 minutes after every 2 hours continuous usage.
For complete body protection use a combination of a suitable apron with head protection. protection eyewear, thyroid shield, sleeve, gonad or ovarian shield or patient apron for maximum protection
Selection of protection level of an apron or any protection equipment should be done keeping in consideration the working environment, duration of usage and minimum protection required to protect the user from scattered X-ray radiation.
PPE products placed in the European market are subject to the Regulation (EU) 2016/425. They are subject to essential requirements to Safety, Health and Environment and to EU Type Examination procedure or module B. As regards to the selection and use of a PPE, we remind that it has to be done in accordance with Regulation (EU) 2016/425.
